Consider Kogenate^® FS

Kogenate FS offers rFVIII users a reliable alternative when you need to change your rFVIII therapy.

If your supplier no longer offers the recombinant factor VIII product you use and you're looking for a product that offers real convenience and protection, consider Kogenate FS antihemophilic factor (recombinant) with BIO-SET® needleless reconstitution system.

Real efficacy

• Real joint protection when used as routine prophylaxis in children (0-16 years) with no preexisting joint damage^{1 2}
• Documented history of efficacy in PUPs, PTPs and MTPs¹

Real safety

• Low rate of inhibitor development in clinical studies with PUPs, PTPs and MTPs¹
• The most serious adverse reactions are systemic hypersensitivity reactions and the development of hightiter inhibitors necessitating alternative treatments to AHF. The most common adverse reactions observed in clinical trials were inhibitor formation in previously treated or minimally treated patients, skin-associated hypersensitivity reactions, infusion site reactions, and central venous access device (CVAD) line-associated infections.
• Multistep purification process with 2 virus inactivation steps
• No FVIII inhibitors developed in 72 PTPs who received Kogenate FS for up to 54 exposure months.¹
  In trials with PUPs and MTPs, 88% of patients (53 of 60) achieved 20 or more exposure days,¹ and the incidence of inhibitor formation (15%) was consistent with that observed in other pediatric studies using FVIII products.³
  In the pediatric prophylaxis clinical trial, de novo inhibitor development was observed in 8 of 64 patients with negative baseline values (12.5%).
  Two patients developed high-titer inhibitors and were withdrawn from the study.
• Exclusive anti-counterfeiting and tamper-evident features for protection
  • Bayer HealthCare is the first rFVIII manufacturer to provide these important links in the chain of protection

Real convenience

• A self-contained, needleless rFVIII reconstitution system
• Convenient Grab & Go packaging containing materials necessary for safe reconstitution and fast rFVIII treatment
• One of the smallest diluent volumes available**
• May be administered over 1-15 minutes. The appropriate rate of administration should be determined by a healthcare provider.
• Should be stored under refrigeration, or can be stored at room temperature for up to 3 months
• Kogenate® FS with BIO-SET® is widely covered on commercial insurance plans and by Medicare and Medicaid

Please consult with your healthcare provider to determine if Kogenate FS is appropriate for you.

Now you can try Kogenate FS with BIO-SET at no cost, to see if it's right for you.

To find out more about the real life protection of Kogenate FS, contact your Bayer Account Executive.

* Up to 6 free samples/doses to a maximum of 5,000 IU for new patients and 20,000 IU for previously treated patients.

** 2.5 mL for 250 IU, 500 IU and 1000 IU product sizes; 5.0 mL for 2000 IU and 3000 IU product sizes.

References:

1. Kogenate FS with Bio-Set [package insert]. Tarrytown, NY: Bayer HealthCare LLC; 2009.
2. Manco-Johnson MJ, Abshire TC, Shapiro AD, et al. Prophylaxis versus episodic treatment to prevent joint disease in boys with severe hemophilia. N Engl J Med. 2007;357(6):535-544.
3. Kreuz W, Gill JC, Rothschild C, et al; International Kogenate-FS Study Group. Full-length sucrose-formulated recombinant factor VIII for treatment of previously untreated or minimally treated young children with severe haemophilia A: results of an international clinical investigation. Thromb Haemost. 2005;9(3):457-467.